About the job
Join CSL Seqirus as a Regulatory Affairs Manager and be part of a team that is dedicated to making a meaningful difference in the lives of patients. This exciting opportunity allows you to contribute to the growth of in-licensed products while ensuring regulatory compliance and fostering collaboration across various teams. The team values open communication and a proactive approach, making it a great fit for those who thrive in a dynamic environment.
You'll be responsible for
📝
Preparing regulatory strategies
Preparing regulatory strategies for submission of new products or line extensions as well as for ensuring ongoing regulatory compliance.📑
Submitting applications
Planning, preparing and submitting high-quality applications in Australia/New Zealand including Category 1/3 applications, responses to evaluation reports and agency questions.🌐
Collaborating with teams
Collaborating cross-functionally with medical, safety, and commercial teams to develop high-quality PI, CMI, and labelling materials tailored to the Australian and New Zealand markets.Key criteria
📄
Regulatory submission experience
Proven track record of successful regulatory submissions in Australia and New Zealand.View
📚
TGA and Medsafe knowledge
Excellent working knowledge of TGA and Medsafe requirements and guidelines.View
💬
Communication skills
Well-developed verbal and written communication skills focused on solutions.View
View more
